CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 48 enrolled
Drug / intervention
Nutrition time control/placebo intervention +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01643044
NCT01643044Phase 1Completed
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Computer-delivered SBIRT for Alcohol Use in Pregnancy: Planning a Stage II Trial

Wayne State University·interventional·Posted Jul 17, 2012·Updated Aug 1, 2014

In Brief

A Phase 1 clinical trial evaluating Nutrition time control/placebo intervention and Computer-delivered, brief intervention on alcohol use for Alcohol Abuse. Completed, enrolled 48 participants across 1 site.

Detailed Summary

The purpose of this study is to lay the ground work for a fully powered clinical trial of a computer-delivered screener and intervention for alcohol use during pregnancy. The pilot study will include: 1. Evaluation of the usefulness of handheld devices and anonymous screening for self report of at-risk alcohol use among pregnant women. 2. Assessing the validity of an alcohol biomarker, Ethyl Glucoronide (EtG), for the detection of at-risk drinking in pregnant women. 3. Evaluation of the efficacy of a computer-delivered brief intervention and use of tailored handouts to supplement the computer-based brief intervention focusing on alcohol use during pregnancy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcohol Abuse
CountriesUnited States
CollaboratorsNational Institute on Alcohol Abuse and Alcoholism (NIAAA)

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 17, 2012
Enrollment StartApr 1, 2011
Primary CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 14.0 years ago

Interventions

Nutrition time control/placebo interventionbehavioral

This time-control intervention, designed in part to help promote research assistant blinding as to participant condition, focused on proper infant nutrition using a computer-delivered, interactive format and videos.

Computer-delivered, brief intervention on alcohol usebehavioral

A single 20-minute interactive computer-delivered intervention designed to promote motivation to change prenatal alcohol use, without presuming the participant to be currently using alcohol while pregnant.